Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000941561
Ethics application status
Approved
Date submitted
23/01/2024
Date registered
5/08/2024
Date last updated
5/08/2024
Date data sharing statement initially provided
5/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and acceptability of Collaborative Assessment and Management of Suicidality (CAMS) in an Australian inpatient setting
Scientific title
Feasibility and acceptability of Collaborative Assessment and Management of Suicidality (CAMS) in an Australian inpatient setting
Secondary ID [1] 311396 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicidality 332669 0
Condition category
Condition code
Mental Health 329376 329376 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Collaborative Assessment and Management of Suicide (CAMS) framework is a clinical philosophy of care (https://cams-care.com). It is an evidence-based framework used to assess suicidality and inform and guide the treatment and care planning process for people who are suicidal and are at risk. It is a flexible approach that can be used across theoretical orientations and disciplines and has been used across treatment settings and treatment modalities. A collaborative and person-centered focus is fundamental to CAMS with the aim being to have the consumer be the co-author of their treatment plan.

Delivery of CAMS typically involves three specific phases: an initial session of assessment and treatment planning, interim sessions that focus on monitoring and understanding current suicide risk and treatment of suicidal drivers and a final session that looks at outcomes and next steps. Completion of the Suicide Status Form is a key part of delivering CAMS that functions as a clinical roadmap for assessment, treatment planning, tracking of ongoing risk, and, ultimately, clinical outcomes. Safety planning (called a Stabilisation Plan) is part of the first CAMS session.

CAMS can be delivered face to face or virtually and is usually delivered one-to-one. CAMS is delivered by a mental health clinician. Sessions are delivered over a timeframe negotiated between therapist and consumer. Weekly or fortnightly appointments are not unusual because of the presence of suicide risk. Sessions typically are delivered over 45-60 minutes and duration of treatment is determined by resolution of suicidality (three consecutive sessions where consumer rates 1 or 2 on the 'Rate Overall Risk of Suicide' question, reports 'yes' on the 'Managed Thoughts/Feelings in the past week' and reports 'no' on 'Suicidal behaviour in the past week' items within the Suicide Status Form Core Assessment). This means the minimum number of sessions to reach resolution is four, while the maximum number of sessions that may be offered is unlimited. The modal number of sessions offered in RCTs is 6-8.

For this study, as informed by other inpatient CAMS studies, we propose having CAMS delivered twice weekly face to face and one-on-one during the inpatient stay (as per Ellis, 2017). The key components to deliver (as suggested by Hershey, 2016) during short term inpatient settings is development of a stabilization (safety) plan, discussions about access to lethal means of suicide and preliminary identification of issues in need of treatment (i.e. suicidal drivers) including early work on these, including planning for addressing drivers in post-hospital aftercare. Sessions will take up to an hour and may be delivered in components if required.

For this study, CAMS will be delivered by clinical psychologists or clinical psychologists in training who have completed CAMS training. CAMS training comprises reading the manual (Managing Suicidal Risk by Prof David Jobes) and completing the online education modules. The 265 page manual provides an overview of the development of CAMS and an overview and guided orientation to each of the core components of CAMS, including the Suicide Status Form, coauthoring a suicide-specific treatment plan, tracking suicide risk assessments and treatment plan updates and discharge planning. The book provides a summary of the principles behind each component, the research relevant to each component, a description of how the activity should be completed and a case study description of how the activity was used in practice. The online modules take approximately 8 hours to complete and combine didactic teaching and skills demonstration through role plays. They cover the same content as the manual but are focused on the key messages and demonstrating the activities in practice. Clinicians complete a knowledge test at the end of the course. The manual and the online modules cover all components needed to deliver CAMS including engaging people with suicide prevention-focused treatment, orientation and use of the CAMS forms, treatment strategies, therapy closure and documentation. Clinicians will complete the training in a self-directed manner prior to consumer recruitment commencing and module and test completion will be reviewed to ensure all components have been completed.

After the clinician participants have completed the training, the research team will meet with the clinician participants as a group to discuss and identify if there are any other specific components of the proposed intervention that need to be adapted to be able to be delivered in this study setting.

Clinicians will attend monthly group supervision virtually with a CAMS-certified clinician during the period consumer recruitment is live. A weekly drop-in session with a local senior clinical psychologist experienced with CAMS will also be available to clinician participants during the period consumer recruitment is open. The purpose of these forums is to discuss practice-related issues in delivering CAMS and receive advice about how to proceed. Attendance logs will be kept for both forums.

Review of completion of CAMS forms as stored within the consumer's medical record will also occur to capture fidelity to treatment.

A focus group with clinicians will be conducted at the completion of consumer recruitment. The focus group will focus on clinicians' experience of the delivering CAMS, barriers and facilitators and learnings from the trial about the fit of the intervention within the inpatient setting. The focus group will be facilitated by a clinical psychologist with experience in running focus groups and a good understanding of CAMS, supported by an experienced research officer familiar with service delivery in inpatient settings and qualitative research. All clinician participants who chose to be involved will be able to be involved. Focus groups will be run with up to 8 people.
Intervention code [1] 327835 0
Treatment: Other
Intervention code [2] 327836 0
Behaviour
Intervention code [3] 327837 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337198 0
Feasibility as indicated by 80% of consumer participants receiving 1 session of CAMS during hospital stay
Timepoint [1] 337198 0
Hospital discharge (on average, ~2 weeks after admission/recruitment)
Primary outcome [2] 337199 0
Consumer acceptability as indicated by <20% of consumer participants disengaging (choosing not to continue) from CAMS while in hospital.
Timepoint [2] 337199 0
Hospital discharge (on average, ~2 weeks after admission/recruitment)
Secondary outcome [1] 431028 0
Feasibility indicated by 100% of clinician participants completing CAMS training
Timepoint [1] 431028 0
Four months after invitation to complete training
Secondary outcome [2] 431029 0
Feasibility indicated by consumer recruitment target being reached (3 consumer participants per clinician within 3 months)
Timepoint [2] 431029 0
Four months after consumer recruitment phase commences
Secondary outcome [3] 431030 0
Feasibility indicated by refusal rate to take part in study being less than 50%
Timepoint [3] 431030 0
Four months after consumer recruitment phase commences
Secondary outcome [4] 431031 0
Acceptability indicated by positive feedback about intervention from consumer participants
Timepoint [4] 431031 0
One week after discharge from hospital.
Secondary outcome [5] 431032 0
Consumer positive attitudes towards the intervention- re: acceptability
Timepoint [5] 431032 0
For consumer participants, at discharge (on average, ~2 weeks after admission/recruitment).
Secondary outcome [6] 431033 0
Acceptability indicated by number of adverse events (<1) associated with intervention
Timepoint [6] 431033 0
End of the trial (4 months after commencement of consumer particpcipant recruitment period)
Secondary outcome [7] 431034 0
Suicidal ideation
Timepoint [7] 431034 0
Baseline, discharge (on average, ~2 weeks after admission/recruitment), four weeks post-recruitment
Secondary outcome [8] 431035 0
Depression
Timepoint [8] 431035 0
Baseline, discharge (on average, ~2 weeks after admission/recruitment), four weeks post-recruitment
Secondary outcome [9] 431036 0
Suicidal behaviour
Timepoint [9] 431036 0
Baseline, discharge (on average, ~2 weeks after admission/recruitment), four weeks post-recruitment
Secondary outcome [10] 431037 0
Acceptability indicated by consumer satisfaction with treatment
Timepoint [10] 431037 0
Discharge only (on average, 2 weeks after admission/recruitment)
Secondary outcome [11] 431038 0
Engagement with community mental health services
Timepoint [11] 431038 0
Four weeks post-discharge
Secondary outcome [12] 431039 0
Re-presentations to Emergency Department of psychiatric units for mental health and/or self-harm or suicidal concerns
Timepoint [12] 431039 0
Four months post-discharge
Secondary outcome [13] 437620 0
Acceptability indicated by positive feedback about intervention from clinicians
Timepoint [13] 437620 0
At the end of the trial (at least four months after consumer recruitment commences)
Secondary outcome [14] 437621 0
Clinician positive attitudes towards treatment- re: acceptability
Timepoint [14] 437621 0
At the end of the trial (at least four months after consumer recruitment commences)
Secondary outcome [15] 438055 0
Consumer positive attitudes towards the intervention- re: appropriateness
Timepoint [15] 438055 0
For consumer participants, at discharge (on average, ~2 weeks after admission/recruitment).
Secondary outcome [16] 438056 0
Consumer positive attitudes towards the intervention- re: feasibility
Timepoint [16] 438056 0
For consumer participants, at discharge (on average, ~2 weeks after admission/recruitment).
Secondary outcome [17] 438057 0
Consumer positive attitudes towards the intervention- re: useability
Timepoint [17] 438057 0
For consumer participants, at discharge (on average, ~2 weeks after admission/recruitment).
Secondary outcome [18] 438058 0
Clinician positive attitudes towards treatment- re: acceptability
Timepoint [18] 438058 0
At the end of the trial (at least four months after consumer recruitment commences)
Secondary outcome [19] 438059 0
Clinician positive attitudes towards treatment- re: feasibility
Timepoint [19] 438059 0
At the end of the trial (at least four months after consumer recruitment commences)
Secondary outcome [20] 438062 0
Clinician positive attitudes towards treatment- re: useability
Timepoint [20] 438062 0
At the end of the trial (at least four months after consumer recruitment commences)

Eligibility
Key inclusion criteria
Clinician participants: Employed as a psychologist on an acute mental health inpatient unit within the Hunter New England Local Health District (NSW, Australia).

Consumer participants:
- Adults (18+ years) admitted to an acute mental health inpatient unit within the Hunter New England Local Health District (NSW, Australia) that has a psychologist trained in CAMS.
- Report suicidality at admission or a recent suicide attempt (within a month before admission)
- Able to provide informed consent about their treatment (assessed by treating team)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinician participants:
Employed on a temporary contract that will cease during the consumer recruitment period.

Consumer participants:
Not able to provide informed consent about their treatment
Cognitive impairment (e.g. major memory problems, unable to follow straightforward instructions) to the degree that it would significantly affect capacity to engage in psychological treatment, as assessed by the treating team
Requires interpreter support to engage in psychological treatment
Care plan contraindicates CAMS

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/08/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26079 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 26080 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment postcode(s) [1] 41934 0
2298 - Waratah
Recruitment postcode(s) [2] 41935 0
2340 - Tamworth

Funding & Sponsors
Funding source category [1] 315655 0
Hospital
Name [1] 315655 0
Hunter New England Mental Health Service
Country [1] 315655 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Edith St, Waratah
Country
Australia
Secondary sponsor category [1] 317760 0
None
Name [1] 317760 0
Address [1] 317760 0
Country [1] 317760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314539 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 314539 0
Ethics committee country [1] 314539 0
Australia
Date submitted for ethics approval [1] 314539 0
30/06/2023
Approval date [1] 314539 0
25/07/2023
Ethics approval number [1] 314539 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131942 0
Dr Katie McGill
Address 131942 0
Hunter New England Mental Health Service, Edith St, Waratah, NSW, 2298
Country 131942 0
Australia
Phone 131942 0
+61 0418776029
Fax 131942 0
Email 131942 0
katherine.mcgill@health.nsw.gov.au
Contact person for public queries
Name 131943 0
Katie McGill
Address 131943 0
Hunter New England Mental Health Service, Edith St, Waratah, NSW, 2298
Country 131943 0
Australia
Phone 131943 0
+61 0418776029
Fax 131943 0
Email 131943 0
katherine.mcgill@health.nsw.gov.au
Contact person for scientific queries
Name 131944 0
Katie McGill
Address 131944 0
Hunter New England Mental Health Service, Edith St, Waratah, NSW, 2298
Country 131944 0
Australia
Phone 131944 0
+61 0418776029
Fax 131944 0
Email 131944 0
katherine.mcgill@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Was not included in ethics submission/approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21471Study protocol  katherine.mcgill@health.nsw.gov.au
21472Analytic code  katherine.mcgill@health.nsw.gov.au
21473Statistical analysis plan  katherine.mcgill@health.nsw.gov.au
21474Informed consent form  katherine.mcgill@health.nsw.gov.au
21475Clinical study report  katherine.mcgill@health.nsw.gov.au
21476Ethical approval  katherine.mcgill@health.nsw.gov.au
21477Data dictionary  katherine.mcgill@health.nsw.gov.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.